FDA to modify FSMA

December 20th, 2013

Food and Drug Administration (FDA) Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, released a statement on Dec. 19 announcing that the FDA will propose modified rule language and open up an additional comment period on two of the rules under the Food Safety Modernization Act (FSMA).

“FDA appreciates and takes very seriously the extensive input we have received from produce farmers and others in the agricultural sector on the proposed FDA FSMA rules on produce safety and preventive controls for human food, which we published in January 2013,” Taylor said. “We have made every effort to solicit input on the proposed rules, not only through the standard rulemaking process, but also by participating in more than 150 meetings and by travelling to numerous farms of varying types and sizes from Maine to California. To ensure broad input and facilitate constructive dialogue with the produce community, FDA has extended the comment periods on the proposed rules three times.

“Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement.”

The two rules include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. “We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.”

Joel G. Newman, president and chief executive officer, American Feed Industry Association, reacted positively to the announcement. “The American Feed Industry Association is pleased with the U.S. Food and Drug Administration’s decision to release changes, derived by the industry, to the proposed Food Safety Modernization Act’s preventive controls rules. FDA’s decision shows the agency’s recognition of the rules’ complexity and their willingness to take the extra step to ensure the final rules will be as practical as possible for implementation by the industry.

“No rule is perfect, but AFIA acknowledges FDA’s intent to make these rules well suited for everyone involved in various industry segments. This is a positive sign for the future of FSMA. AFIA will continue to work hand-in-hand with FDA as we move forward in this process.”